The goal of this single-arm study is to evaluate the efficacy and safety of Envafolimab combined with Trifluridine/Tipiracil and Bevacizumab in the treatment of metastatic colorectal cancer patients who are refractory or intolerant to standard therapy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
33
150mg Qw, delivered as a single 1.5ml subcutaneous injection in under 30s , every 4 weeks for one cycle(Q4w).
35 mg/m2 (maximum single dose of 80 mg), po, on days 1-5 and 8-12 of each treatment cycle, twice daily for 28 days, within 1 hour after breakfast or dinner take medicine.
ivgtt, 5mg/kg, d1, d15, every 4 weeks for one cycle (Q4w). The subjects will receive Trifluridine/Tipiracil plus Bevacizumab and Envafolimab until disease progression, intolerable toxicity, initiation of other anti-tumor therapy, death, withdrawal of informed consent, or loss of follow-up.
The First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu, China
RECRUITINGORR(Objective response rate)
Objective Response Rate defined as the proportion of patients with objective evidence of complete response (CR) or partial response (PR) according to RECIST version 1.1 criteria and using investigator's tumor assessment.
Time frame: Approximately 12 months
OS (Overall Survival)
Overall survival defined as the observed time elapsed between the date of first treatment and the date of death due to any cause.
Time frame: Approximately 12 months
PFS (Progression-free survival)
Progression-free survival defined as the time elapsed between the randomization and the date of radiologic tumour progression according to RECIST version 1.1 by investigator's judgement or death from any cause, whichever comes first.
Time frame: Approximately 12 months
DCR (Disease control rate)
Disease control rate defined as the proportion of patients with objective evidence of CR or PR or stable disease (SD) according to RECIST version 1.1 criteria and using investigator's tumor assessment.
Time frame: Approximately 12 months
Quality of life: EORTC QLQ-C30
Assess patients health and activities using the European Organization for Research and Treatment of Cancer Core Quality of Life (EORTC QLQ-C30) module.
Time frame: Approximately 12 months
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